Smoking CessationNCT03499340
Pictorial Warning Labels & Memory for Relative & Absolute Cigarette Health-risk Information Over Time in Adult Smokers
A study testing text-only PWL, low arousal graphic PWL and high arousal graphic PWL in people with Smoking Cessation and Smoking, Cigarette, run by Ohio State University at 1 site in United States.
Trial summary
Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks. In this study, adult smokers are repeatedly exposed to text-only vs. low arousal graphic vs. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Cigarette
- What is being tested?
- text-only PWL, low arousal graphic PWL and high arousal graphic PWL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,213 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2017to 3 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- have smoked 100+ lifetime cigarettes
- currently smoke "every day" or "some days."
Who cannot join
- have not ever smoked a cigarette
Trial locations and contacts
1 site in 1 country.
About this study
Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks. In this study, adult smokers are repeatedly exposed to text-only vs. low arousal graphic vs. high arousal graphic warning labels paired with numeric risk information. This study will allow the investigators to assess the extent to which reactions to warnings remain consistent over time and influence smoking risk perceptions and quit intentions. The investigators will also assess the impact of graphic images on memory for smoking risk information presented in absolute (a smoker's lifetime risk of getting a smoking related disease) versus relative (a smoker's risk of getting a smoking related disease, compared to the risk of non-smokers) formats.
- Conditions
- Smoking Cessation, Smoking, Cigarette
- Being tested
- text-only PWL, low arousal graphic PWL, high arousal graphic PWL, absolute risk, relative risk
- Keywords
- pictorial warning labels, risk knowledge, emotion, memory, risk perceptions, quit intentions
- Medical subject headings
- Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text-only PWLBehavioural
control condition (no image)
low arousal graphic PWLBehavioural
pictorial warning
high arousal graphic PWLBehavioural
pictorial warning
absolute riskBehavioural
Percentage risk information for smoking-related diseases for smokers
relative riskBehavioural
Percentage risk information for smoking-related diseases for smokers and non-smokers
| Study group | Role | What they receive |
|---|---|---|
| Text-only PWL, absolute risk | Experimental | Exposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease Receives: Behavioral: text-only PWL; Behavioral: absolute risk |
| Text-only PWL, relative risk | Experimental | Exposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease Receives: Behavioral: text-only PWL; Behavioral: relative risk |
| Low arousal graphic PWL, absolute risk | Experimental | Exposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease Receives: Behavioral: low arousal graphic PWL; Behavioral: absolute risk |
| Low arousal graphic PWL, relative risk | Experimental | Exposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease Receives: Behavioral: low arousal graphic PWL; Behavioral: relative risk |
| High arousal graphic PWL, absolute risk | Experimental | Exposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease Receives: Behavioral: high arousal graphic PWL; Behavioral: absolute risk |
| High arousal graphic PWL, relative risk | Experimental | Exposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease Receives: Behavioral: high arousal graphic PWL; Behavioral: relative risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric risk recognition
Participants answered one multiple choice question about the numeric risk for smokers for each label (e.g., ____% of smokers die before age 85). For each question, there were four decoy responses.
Measured: measured immediately following last exposure
Secondary outcomes (13)
numeric risk recognition
Participants answered one multiple choice question about the numeric risk for smokers for each label (e.g., ____% of smokers die before age 85). For each question, there were four decoy responses.
Measured: measured after 6-week delay
relative risk recognition
Participants answered one multiple choice question about the numeric risk for smokers vs. nonsmokers for each health risk (e.g., a smoker is ____ as likely to die from heart disease as a nonsmoker). For each question, there were three decoy responses (e.g., for heart disease, response options were: "about as likely," "1.75 times," "4.1 times," "10.4 times").
Measured: measured immediately following last exposure
relative risk recognition
Participants answered one multiple choice question about the numeric risk for smokers vs. nonsmokers for each health risk (e.g., a smoker is ____ as likely to die from heart disease as a nonsmoker). For each question, there were three decoy responses (e.g., for heart disease, response options were: "about as likely," "1.75 times," "4.1 times," "10.4 times").
Measured: measured after 6-week delay
smoking risk perceptions
Participants completed several scale items about how much risk they perceived smoking posed to them (e.g., "If a person smokes at your age, how likely are they to get a life-threatening illness from smoking someday ?" [1=very unlikely; 5=extremely likely])
Measured: measured immediately following last exposure
smoking risk perceptions
Participants completed several scale items about how much risk they perceived smoking posed to them (e.g., "If a person smokes at your age, how likely are they to get a life-threatening illness from smoking someday ?" [1=very unlikely; 5=extremely likely])
Measured: measured after 6-week delay
quit intentions (for next 30 days)
Participants intentions to quit smoking; self-reported likelihood of smoking "within the next 30 days" (-3 = very unlikely, 3 = very likely)
Measured: measured immediately following last exposure
quit intentions (for next 30 days)
Participants intentions to quit smoking; self-reported likelihood of smoking "within the next 30 days" (-3 = very unlikely, 3 = very likely)
Measured: measured after 6-week delay
quit intentions (for next year)
Participants intentions to quit smoking; self-reported likelihood of smoking "within next year" (-3 = very unlikely, 3 = very likely)
Measured: measured immediately following last exposure
quit intentions (for next year)
Participants intentions to quit smoking; self-reported likelihood of smoking "within next year" (-3 = very unlikely, 3 = very likely)
Measured: measured after 6-week delay
risk recognition
Participants were given a list of 9 warnings and asked to select which ones they'd been previously exposed to
Measured: measured immediately following last exposure
risk recognition
Participants were given a list of 9 warnings and asked to select which ones they'd been previously exposed to
Measured: measured after 6-week delay
feelings about smoking
Participants completed several scale items about their feelings towards smoking (e.g., "How good or bad do you feel about smoking?" -2=very bad; +2=very good; "How much do you feel confused about the harms vs. benefits of smoking?" 0=not at all confused; 4=very confused)
Measured: measured immediately following last exposure
feelings about smoking
Participants completed several scale items about their feelings towards smoking (e.g., "How good or bad do you feel about smoking?" -2=very bad; +2=very good; "How much do you feel confused about the harms vs. benefits of smoking?" 0=not at all confused; 4=very confused)
Measured: measured after 6-week delay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start10 Jul 2017
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Ellen Peters, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499340
- Sponsor's protocol ID
- P50CA180908A2a-A
- Other IDs
- P50CA180908
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pictorial Warning Labels & Memory for Relative & Absolute Cigarette Health-risk Information Over Time in Adult Smokers
- ClinicalTrials.gov ID
- NCT03499340
- Acronym / sponsor ID
- P50CA180908A2a-A
- Conditions
- Smoking Cessation, Smoking, Cigarette
- Keywords
- pictorial warning labels, risk knowledge, emotion, memory, risk perceptions, quit intentions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,213 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks. In this study, adult smokers are repeatedly exposed to text-only vs. low arousal graphic vs. high arousal graphic warning labels paired with numeric risk information. This study will allow the investigators to assess the extent to which reactions to warnings remain consistent over time and influence smoking risk perceptions and quit intentions. The investigators will also assess the impact of graphic images on memory for smoking risk information presented in absolute (a smoker's lifetime risk of getting a smoking related disease) versus relative (a smoker's risk of getting a smoking related disease, compared to the risk of non-smokers) formats.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Text-only PWL, absolute risk | Experimental | Behavioral: text-only PWL, Behavioral: absolute riskExposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk of a smoking-related disease |
| Text-only PWL, relative risk | Experimental | Behavioral: text-only PWL, Behavioral: relative riskExposure to FDA-mandated warning labels, without a graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease |
| Low arousal graphic PWL, absolute risk | Experimental | Behavioral: low arousal graphic PWL, Behavioral: absolute riskExposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease |
| Low arousal graphic PWL, relative risk | Experimental | Behavioral: low arousal graphic PWL, Behavioral: relative riskExposure to FDA-mandated warning labels, paired with a low arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease |
| High arousal graphic PWL, absolute risk | Experimental | Behavioral: high arousal graphic PWL, Behavioral: absolute riskExposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk of a smoking-related disease |
| High arousal graphic PWL, relative risk | Experimental | Behavioral: high arousal graphic PWL, Behavioral: relative riskExposure to FDA-mandated warning labels, paired with a high arousal graphic image, accompanied by risk information about smoker's risk and non-smoker's risk of a smoking-related disease |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- have smoked 100+ lifetime cigarettes
- currently smoke "every day" or "some days."
Key exclusion criteria (1 listed)
- have not ever smoked a cigarette
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| text-only PWLcontrol condition (no image) | Behavioural | Text-only PWL, absolute risk, Text-only PWL, relative risk |
| low arousal graphic PWLpictorial warning | Behavioural | Low arousal graphic PWL, absolute risk, Low arousal graphic PWL, relative risk |
| high arousal graphic PWLpictorial warning | Behavioural | High arousal graphic PWL, absolute risk, High arousal graphic PWL, relative risk |
| absolute riskPercentage risk information for smoking-related diseases for smokers | Behavioural | High arousal graphic PWL, absolute risk, Low arousal graphic PWL, absolute risk, Text-only PWL, absolute risk |
| relative riskPercentage risk information for smoking-related diseases for smokers and non-smokers | Behavioural | High arousal graphic PWL, relative risk, Low arousal graphic PWL, relative risk, Text-only PWL, relative risk |
Primary outcome
numeric risk recognition
Time frame: measured immediately following last exposure
Participants answered one multiple choice question about the numeric risk for smokers for each label (e.g., ____% of smokers die before age 85). For each question, there were four decoy responses.
13 secondary outcomes
numeric risk recognition
Time frame: measured after 6-week delay
relative risk recognition
Time frame: measured immediately following last exposure
relative risk recognition
Time frame: measured after 6-week delay
smoking risk perceptions
Time frame: measured immediately following last exposure
smoking risk perceptions
Time frame: measured after 6-week delay
quit intentions (for next 30 days)
Time frame: measured immediately following last exposure
quit intentions (for next 30 days)
Time frame: measured after 6-week delay
quit intentions (for next year)
Time frame: measured immediately following last exposure
quit intentions (for next year)
Time frame: measured after 6-week delay
risk recognition
Time frame: measured immediately following last exposure
risk recognition
Time frame: measured after 6-week delay
feelings about smoking
Time frame: measured immediately following last exposure
feelings about smoking
Time frame: measured after 6-week delay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text-only PWL, low arousal graphic PWL and high arousal graphic PWL in people with Smoking Cessation and Smoking, Cigarette, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric risk recognition (time frame: measured immediately following last exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.